Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Analyzing metabolic pathways in hormone receptor positive breast cancer

Official title: Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

Run by Rutgers, The State University of New Jersey · NCT05736367 · Data updated 2026-11-12

This study tests how a special glucose infusion during breast cancer surgery can help researchers understand the metabolism of hormone receptor positive breast cancer to improve future treatments.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment16 (estimated)
SponsorRutgers, The State University of New Jersey
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations2 sites (New Brunswick, New Jersey and 1 other locations)
StatusRecruiting
StartedNovember 15, 2024
Main results expectedJune 30, 2026
Study endsJune 30, 2028
Registry record updatedJanuary 21, 2026
Trial IDNCT05736367 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with early-stage hormone receptor positive/HER2 negative breast cancer who are scheduled for surgical resection.

Probably not a fit

Patients with triple negative or HER2 positive breast cancer, as well as those currently enrolled in other clinical studies involving investigational therapies, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the metabolic activity of hormone receptor positive (HR+)/HER2 negative breast cancer by administering a U-13C-glucose infusion during routine breast cancer surgery. Participants will undergo tumor and blood sample collection to analyze the metabolic processes of the tumor. The study duration for each patient is three to four weeks, including a two to three hour glucose infusion and biopsy procedures. The goal is to gain insights into the tumor's metabolic behavior, which may inform future treatment strategies.

Why it matters

Potential benefit: If successful, this study could enhance understanding of breast cancer metabolism, potentially leading to more effective treatment options.

How similar studies have gone: While this approach is innovative, similar studies investigating metabolic pathways in cancer have shown promise, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
* Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0)
* Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
* Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection.

Exclusion Criteria:

* Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.
* Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
* Concomitant active malignancy
* Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)

Where it's running

  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey, United States
    Recruiting
  • RWJBarnabas Health
    New Brunswick, New Jersey, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Coral Omene, MD, PhD — Cancer Institute of New Jersey Rutgers
  • Study coordinator: Coral Omene, MD, PhD
  • Email: co273@cinj.rutgers.edu
  • Phone: 732-235-3374

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.